Drug giant on trial

SIDE EFFECTS: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial. By Alison Bass. Algonquin Books of Chapel Hill. 260 pages. $24.95.

The premise of "Side Effects" is that pharmaceutical giant GlaxoSmithKline knowingly hid the fact its best-selling drug, Paxil (paroxetine), could be ineffective and might cause suicidal ideation when prescribed for adolescents and children.

In fast-moving prose that reads like a suspense novel, investigative journalist Alison Bass introduces the reader to the main players through short biographies. In particular, she profiles lead prosecutor Rose Firestein of the N.Y. attorney general's office. Firestein uncovered the GSK memo that stated, "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."

The result of her GSK investigation led to New York's lawsuit against the company for consumer fraud. In the settlement, GSK agreed to publish a registry with negative and positive results of its clinical trials. Fearing litigation, other pharmaceutical companies voluntarily published their negative results as well.

The book discloses the relationships among drug companies, researchers and physicians with the Food and Drug Administration, which received almost $400 million in user fees from the pharmaceutical industry in fiscal 2008. Bass questions the wisdom of the FDA's close ties to drug manufacturers.